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_|Booster vaccination may help with possible future avian influenza pandemic|_

Giuseppe

Emeritus
Booster vaccination may help with possible future avian influenza pandemic

New evidence suggests that a booster vaccination against H5N1 avian influenza given years after initial vaccination with a different strain may prove useful in controlling a potential future pandemic.

The study is published in the August 1 issue of The Journal of Infectious Diseases, now available online.

H5N1 continues to pose a major health risk to birds and humans.

As of mid-June, more than 60 percent of the more than 380 human cases have been fatal, and hundreds of millions of birds have died or been culled to prevent the spread of the disease.

Should the virus evolve making human-to-human transmission more likely, a destructive global influenza pandemic could result.

The cornerstone of planning for such a possible pandemic is the development and distribution of effective vaccines.

Several vaccines have been developed, but as the virus continues to mutate into genetically distinct lineages, or clades, the problem arises as to whether vaccines based on an older clade will be effective against newer versions.

The new study is the first to report that giving one dose of a newer-clade vaccine to those who were vaccinated previously with older versions is more effective than giving only doses of the newer vaccine to unvaccinated subjects.

The study, conducted by Nega Ali Goji, MD, and colleagues from New York, Maryland, and Alabama, gave a single booster dose of a vaccine based on a clade 1 H5N1 virus circulating in Vietnam in 2004 to subjects who eight years earlier had received two doses of a vaccine based on the original, clade 0 virus that appeared in Hong Kong in 1997.

Sixty-four percent had a positive immune response, which compares favorably to the results of a previous study using two doses of the clade 1 Vietnam virus, in which only 43 percent of those vaccinated had a positive immune response.

The results not only support the booster technique, but also show that even though the virus had mutated since the initial vaccination, using it to boost an earlier vaccine is more effective than simply vaccinating subjects with the most current vaccine.

These findings are important given the fact that influenza viruses are mutating constantly.

"These results suggest that one strategy for pandemic control could involve prevaccination of some segments of the population prior to the emergence of a pandemic so that effective protection could be achieved with a single dose schedule if and when a pandemic emerges," the authors wrote.

"If the finding that priming can result in enhanced responses to single-dose vaccination schedules were confirmed, then pre-pandemic vaccination programs could be considered, especially in populations of first responders, health care workers, or the military. Such populations might then be able to be effectively and rapidly vaccinated with a single dose of a vaccine specific for an emerging pandemic if it were to occur."

In an accompanying editorial, Gregory A. Poland, MD, of the Mayo Clinic College of Medicine, noted that some are already looking to begin such prevaccination primers against H5N1 influenza.

For example, Japan is planning to immunize health care workers starting in 2009, and the U.S. Department of Defense is offering a vaccine to those in high risk specialties.

Dr. Poland pointed out that new studies are needed to investigate different types of vaccine administration, deal with vaccinations that prevent death but not infection and illness, search for more broadly cross-protective influenza vaccines, and collect data on the vaccination of those who are not healthy adults.

Although, he said, "determining who should receive these vaccines, when, and in what order and under what circumstances deserves widespread debate," he agrees that the findings of the study are novel, as they "suggest that such a prime-boost strategy using vaccines derived from different H5 clades, separated by years, may be worthwhile, immunologically feasible, and safe."

###
Fast Facts
1) Experts are concerned about a possible pandemic of H5N1 influenza. As of mid-June, 60 percent of the more than 380 human cases have been fatal, and half a billion birds have died or been culled to prevent the spread of the disease. Should the virus evolve making human-to-human transmission more likely, a destructive global influenza pandemic could result.

2) Giving a "booster" vaccine using a recent strain of virus to those previously vaccinated with an older strain was more effective than only vaccinating with the recent strain. Especially relevant is the fact that the primer and booster vaccines were derived from different strains of the virus and still were effective.

Founded in 1904, The Journal of Infectious Diseases is the premier publication in the Western Hemisphere for original research on the pathogenesis, diagnosis, and treatment of infectious diseases; on the microbes that cause them; and on disorders of host immune mechanisms.

Articles in JID include research results from microbiology, immunology, epidemiology, and related disciplines. JID is published under the auspices of the Infectious Diseases Society of America (IDSA). Based in Arlington, Va., IDSA is a professional society representing more than 8,000 physicians and scientists who specialize in infectious diseases. For more information, visit www.idsociety.org.

-
http://www.eurekalert.org/pub_releases/2008-07/idso-bvm071608.php
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Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

hmm, someone suggested recently to inject those prepandemic doses
which are expiring now.
(how many expire in USA ?)

Switzerland's prepandemic vaccine was delivered in 2007
(scheduled Jan., but delayed), it should expire next year (?)


effectivity for seasonal vaccine is so bad, despite all these
boosters each year
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

Shelf life for fda approved vaccine is 18 months.
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

The side efects of these vaccines probably blocked it's administering as a primer/booster, or before the pandemic starts.
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

they could sell it to other countries
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

they could sell it to other countries
Only as "use it now".

Nobody want's additional illnesses from expired drugs/vacc.
Expired meds/vacc. must be treated as vanished, and restocked with new batches.
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

Shelf life for fda approved vaccine is 18 months.
Does influenza vax offer any degree protection after the expiration date?

What do the drug companies do with the expired vax that is returned?

Is there any way to extend shelf-life, like the extension program for Tamiflu?
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

The side efects of these vaccines probably blocked it's administering as a primer/booster, or before the pandemic starts.
What side effects? They are made just like seasonal flu vaccines.
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

Does influenza vax offer any degree protection after the expiration date?

What do the drug companies do with the expired vax that is returned?

Is there any way to extend shelf-life, like the extension program for Tamiflu?

Another question: Would the expiration date begin at the same time for bulk vax as it does for vax in vials; or is the bulk already in vials?
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

the date is just for the lawyers.

It degrades continuously, maybe half as effective after 2 years or such.
In connection with boostering this could be different again
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

the date is just for the lawyers.

It degrades continuously, maybe half as effective after 2 years or such.
In connection with boostering this could be different again
The FDA says 18 months. That's not for lawyers. At 18 months in goes into the garbage. If it is used after 18 months, then the lawyers get involved when the vaccine fails or there are side effects (and damages will be punitive).
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

From this Daily Times article regarding the expired vax we donated to Pakistan earthquake survivors in 2005:
http://www.dailytimes.com.pk/default.asp?page=2006\01\04\story_4-1-2006_pg7_10
Ira Longini, an Emory University bio-statistician, has said that the vaccine could be effective after its expiration date, as long as it’s stored properly. However, it could lose its potency, she added.

Added: It expired in August and they were claiming it was still good after Oct. 8.
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

What side effects? They are made just like seasonal flu vaccines.

Pardon me Dr. Niman, but not quite yet, imo.
The bf vacc. have new (or few years experimented) adiuvants, which are for now used only in small quantities for seasonal vacc.
Maybe that's rapidly changing to do experiments, we'll see.

And as you said well after:
"The FDA says 18 months. That's not for lawyers. At 18 months in goes into the garbage. If it is used after 18 months, then the lawyers get involved when the vaccine fails or there are side effects (and damages will be punitive)."

Obviously if an vaccine have a shelf life means that after that period because of stocking, etc. (I'm shure You know better than me) it became risky to take.
I'm not glad to see possibilities of restamping the shelf-life schedule instead of restocking with fresh ones.

This producers technic of diluting, and procrastinating the expiring because of not vilingness of vasting, and putting money is not good.
Let's the consumer decide if buy a new stock vacc. for more money, or take the expired.

Additionaly, the bulk vacc. doses are already problematic because must be administered when opened sequentialy during 15-20 min. to not loosing efficiency.

This prolonging of Tamiflu shelf life from first 2 years to 5 years, and somewhere 7 years is also a paliative to have this doses instead of restocking by new production. This was initialy meant because of the hurry to create many more strategic antiviral stockpiles in short time.
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

http://www.medpagetoday.com/InfectiousDisease/URItheFlu/tb/10164

'Prime-Boost' Strategy Might Overcome Avian Flu Vaccine Shortage

By Michael Smith, North American Correspondent, MedPage Today
Published: July 18, 2008
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.





<TABLE cellSpacing=0 cellPadding=0 width=500 align=center border=0><TBODY><TR><TD style="PADDING-TOP: 10px">ROCHESTER, N.Y., July 18 -- Initial vaccination, perhaps years before an H5N1 avian flu pandemic, followed by a booster during the outbreak may overcome forecast shortages of vaccine, researchers here said.

A key difficulty in preparing for an avian flu pandemic is that studies have shown that two large doses of an H5N1 vaccine -- nearly 200 micrograms in total -- will be needed to create an immune response in most people, according to John Treanor, M.D., of the University of Rochester, and colleagues.

Given the difficulties of producing a flu vaccine, that would almost certainly mean shortages, they said in the Aug. 1 issue of the Journal of Infectious Diseases. Action Points <!---
2arrows.gif
---><HR style="BORDER-TOP-WIDTH: thin; BORDER-LEFT-WIDTH: thin; BORDER-LEFT-COLOR: #9b9b9b; BORDER-TOP-COLOR: #9b9b9b; BORDER-BOTTOM: #9b9b9b thin dotted; BORDER-RIGHT-WIDTH: thin; BORDER-RIGHT-COLOR: #9b9b9b" width="90%">
  • Explain to interested patients that researchers fear the highly pathogenic H5N1 avian flu may change so that it can easily infect humans, possibly leading to a pandemic.
  • <LI class=APP>Note that while vaccines against H5N1 virus have been made, they require large doses to produce an immune response, which may make them less useful in the event of an outbreak.

    [*]Explain that this study suggests that priming with any H5N1 vaccine allows a robust immune response after boosting with another type of the virus, offering a strategy to overcome shortages.
The solution may be to "prime" large segments of the population with another H5N1 vaccine, perhaps years before an avian flu outbreak, and then "boost" the immune response during an outbreak with a vaccine specific to the causative strain, the researchers said.

Since the highly pathogenic H5N1 virus now circulating in birds is undergoing antigenic shift, a key question is whether that strategy would work.

To answer the question, Dr. Treanor and colleagues looked to a cohort of 37 volunteers vaccinated in 1998 against A/Hong Kong/156/1997 -- a so-called clade 0 strain of H5N1.

In 2006, the volunteers were given a 90-microgram intramuscular dose of a vaccine against A/Vietnam/1203/2004, a clade 1 strain of H5N1, the researchers said.

Their immune responses were compared with those of a cohort of 103 volunteers given two 90-microgram doses of the vaccine against A/Vietnam/1203/2004 in an earlier study. (Early results of this study were reported at the 2006 Infectious Disease Society of America.
See: (IDSA: 'Priming' Strategy Might Eke Out Avian Flu Vaccine)

At baseline, the 37 volunteers had no detectable antibodies to either flu strain, Dr. Treanor and colleagues said.

However, after the single dose of the newer vaccine, their immune response -- the geometric mean titer (GMT) of hemagglutination-inhibition antibody -- was 64.0, with 68% responding.

That was higher than the response seen in the other cohort both after a single shot and after the second dose, the researchers said. The GMTs were 13.3 and 27.7, respectively, with 23% and 43% responding.

There were no serious vaccine-related adverse events in either group, the researchers said.

The finding implies that it is "worth seriously considering" priming the population at large with a pre-pandemic H5N1 vaccine, said Gregory Poland, M.D., of the Mayo Clinic College of Medicine in Rochester, Minn., and Suryaprakash Sambhara, Ph.D., of the CDC.

That might be done either by a separate vaccination or by including the appropriate antigens in the seasonal flu vaccine, they said in an accompanying editorial.

The data reported by Dr. Treanor and colleagues suggests that a prime-boost strategy "may be worthwhile, immunologically feasible, and safe," they said.

While the avian flu so far appears unable to jump easily from humans to humans, it has infected some people and has caused a large proportion of deaths among them. According to the World Health Organization, there have been 385 cases and 243 deaths as of June 19, 2008.
<TABLE style="BORDER-RIGHT: #8dabbc 1px solid; PADDING-RIGHT: 5px; BORDER-TOP: #8dabbc 1px solid; PADDING-LEFT: 5px; FONT-SIZE: 12px; PADDING-BOTTOM: 5px; BORDER-LEFT: #8dabbc 1px solid; PADDING-TOP: 5px; BORDER-BOTTOM: #8dabbc 1px solid; FONT-FAMILY: arial; BACKGROUND-COLOR: #dbe9f2" cellSpacing=0 hspace="1"><TBODY><TR><TD>The researchers did not report external financing for the study. Dr. Treanor reported financial links with Sanofi Pasteur and Protein Sciences Corp. The remaining authors said they had no potential conflicts. Dr. Poland reported financial links with Merck Research Laboratories, CSL Limited, GlaxoSmithKline, Novartis, Protein Sciences, Novavax, PowderMed, and Avianax. Dr. Sambhara reported no conflicts.


</TD></TR></TBODY></TABLE>




</TD></TR><TR><TD>
Primary source: Journal of Infectious Diseases
Source reference:
Goji NA, et al "Immune Responses of Healthy Subjects to a Single Dose of Intramuscular Inactivated Influenza A/Vietnam/1203/2004 (H5N1) Vaccine after Priming with an Antigenic Variant" JID 2008: 198; DOI: 10.1086/590916.

Additional source: Journal of Infectious Diseases
Source reference:
Poland GA, Sambhara S "Vaccines against Influenza A (H5N1): Evidence of Progress" JID 2008: 198; DOI: 10.1086/590916.


</TD></TR></TBODY></TABLE>
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

they seem to ignore the use of adjuvants ?!
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

they seem to ignore the use of adjuvants ?!
For the public ...
The "extreme problem, extreme measures" method.

To not dig out it now, we had many posts/threads here at FT about the adjuvants in the seasonal/... vaccines.

Example:
The squalene based instead of alum. (adjuvant MF59, Novartis, It/EU aproved) - seasonal vaccine Fluad - at the time in USA that adjuvant wasn't aproved yet by the FDA.
Other corp. have other new adjuvants also.

The same ad. was in one trial Fluad H5N1 version.

If we compare the corp. product information from such new, and old adjuvated vaccines, we'll see the declared diferences.

It's a fact that vaccines are crucial to saving many lives from many various illnesses.
But obviously nobody can say if "you are the one to be crippled" nor for seasonal nor for the pandemic vacc.
Some previous WHO/... statements suggested that such pandemic vaccines are to be used ONLY at the real begining of a pandemic.

We have at FT the posts about suspected deaths related to bf vacc. exp. injections recently.

Now seems that things changed.
It's an real necessity to be primed now, or ...

The new adjuvated seasonal vacc. was proclamed under 60-ty/chronic ONLY - because of unknown strong immune responses side efects in a younger population.
Prior, it was exp. in elderly homes.

Some corp. web's about this adjuvant (googled):

<TABLE class="t bt" cellSpacing=0 cellPadding=0 width="100%" border=0><TBODY><TR><TD noWrap>Web </TD><TD noWrap align=right>[SIZE=-1]Results 1 - 10 of about 10,100 for "Fluad". (0.17 seconds) [/SIZE]</TD></TR></TBODY></TABLE>
Pivotal Phase III trial results show Novartis cell culture-derived ...

<TABLE cellSpacing=0 cellPadding=0 border=0><TBODY><TR><TD class=j>19 Oct 2006 ... Novartis MF59-adjuvanted influenza vaccine (FLUAD®) data demonstrate significant protective benefits in adults at risk for post-influenza ...
www.novartisvaccines.com/<WBR>press-room/news/20061019-mf59.shtml - 18k - <NOBR>Cached - Similar pages</NOBR>






</TD></TR></TBODY></TABLE>
Products - Infuenza - Novartis Vaccines

<TABLE cellSpacing=0 cellPadding=0 border=0><TBODY><TR><TD class="j hc">Fluad® The Senior Line: Adjuvanted Flu vaccine for all people aged 65 and over. Active immunization for the elderly, especially for patients with chronic ...
www.novartisvaccines.com/products/influenza.shtml - 12k - <NOBR>Cached - Similar pages</NOBR>
More results from www.novartisvaccines.com »






</TD></TR></TBODY></TABLE>
MF59-adjuvanted Influenza Vaccine (Fluad®) Slashes ...

<TABLE cellSpacing=0 cellPadding=0 border=0><TBODY><TR><TD class=j>15 Nov 2007 ... Older individuals who receive the MF59TM-adjuvanted vaccine (Fluad®) are significantly less likely to require hospitalization during peak ...
www.medicalnewstoday.com/articles/88877.php - 56k - <NOBR>Cached - Similar pages</NOBR>






</TD></TR></TBODY></TABLE>
Vaccine : The virosomal influenza vaccine Invivac®: Immunogenicity ...

<TABLE cellSpacing=0 cellPadding=0 border=0><TBODY><TR><TD class=j>The virosomal influenza vaccine Invivac®: Immunogenicity and tolerability compared to an adjuvanted influenza vaccine (Fluad®) in elderly subjects ...
linkinghub.elsevier.com/retrieve/pii/S0264410X06006207 - <NOBR>Similar pages</NOBR>






</TD></TR></TBODY></TABLE>
Chiromas, (Fluad, MF59 adjuvanted vaccine) more cost-effective ...

<TABLE cellSpacing=0 cellPadding=0 border=0><TBODY><TR><TD class=j>Chiromas, (Fluad, MF59 adjuvanted vaccine) more cost-effective than conventional vaccine in preventing deaths attributable to influenza in 65 years old and ...
gateway.nlm.nih.gov/MeetingAbstracts/103140788.html - 12k - <NOBR>Cached - Similar pages</NOBR>






</TD></TR></TBODY></TABLE>
Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 ...

<TABLE cellSpacing=0 cellPadding=0 border=0><TBODY><TR><TD class=j>This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, ...
clinicaltrials.gov/ct2/show/NCT00434733 - 25k - <NOBR>Cached - Similar pages</NOBR>






</TD></TR></TBODY></TABLE>
Where Fluad Families lived in Scotland in 1891 - Ancestry.com

<TABLE cellSpacing=0 cellPadding=0 border=0><TBODY><TR><TD class=j>View many different Fluad family history facts from birth, marriage, and death records, military records, census records, immigration records, ...
www.ancestry.com/facts/Fluad-family-history-sct.ashx - 29k - <NOBR>Cached - Similar pages</NOBR>






</TD></TR></TBODY></TABLE>
Fluad (Influenza Vaccine) Novartis

<TABLE cellSpacing=0 cellPadding=0 border=0><TBODY><TR><TD class=j>Fluad: Influenza Vaccine trade name; Fluad ingredients names, pharmaceutical forms, destination, category, companies, indications and usages, ...
drugs-about.com/drugs/fluad.html - 9k - <NOBR>Cached - Similar pages</NOBR>






</TD></TR></TBODY></TABLE>
Грипп.ру - все о гриппе. Is the adjuvanted influenza vaccine (AIV ...

<TABLE cellSpacing=0 cellPadding=0 border=0><TBODY><TR><TD class=j>Therefore a new adjuvanted influenza vaccine (AIV, Fluad®) was developed combining subunit influenza antigens with an MF59 adjuvant emulsion. ...
www.gripp.ru/articles/article.aspx?id=3274 - 29k - <NOBR>Cached - Similar pages</NOBR>






</TD></TR></TBODY></TABLE>
FLUAD inj 1x 0.5ml

<NOBR>[SIZE=-1]- [ Translate this page ][/SIZE]</NOBR> <TABLE cellSpacing=0 cellPadding=0 border=0><TBODY><TR><TD class=j>Vakcína (FLUAD) může být podána současně s jinými vakcínami. V tomto případě každá vakcína musí být aplikována vždy do jiné končetiny. ...
www.docsimon.com/article/fluad-inj-1x-0-5ml - 62k - <NOBR>Cached - Similar pages</NOBR>






</TD></TR></TBODY></TABLE>
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

the worse the disease the less you care about side-effects
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

the worse the disease the less you care about side-effects
That's why it was previously suggested it's inoculation only at the begining of a pandemic.
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

However, after the single dose of the newer vaccine, their immune response -- the geometric mean titer (GMT) of hemagglutination-inhibition antibody -- was 64.0, with 68% responding.

That was higher than the response seen in the other cohort both after a single shot and after the second dose, the researchers said. The GMTs were 13.3 and 27.7, respectively, with 23% and 43% responding.


Would the comparison have been done with an identical timeframe, i.e., were antibody tests following the 2nd dose done at the identical #days after innoculation?

I ask because we'd need to eliminate the possiblity that the higher response was due to timing, i.e., within the about-100 days that immunity is always higher after an influenza infection.

This was the basis for the cross-reactive immunity that was discussed here 2 years ago, based on AI cases in ?ducks.

.
 
Re: _|Booster vaccination may help with possible future avian influenza pandemic|_

Would the comparison have been done with an identical timeframe, i.e., were antibody tests following the 2nd dose done at the identical #days after innoculation?

I ask because we'd need to eliminate the possiblity that the higher response was due to timing, i.e., within the about-100 days that immunity is always higher after an influenza infection.

This was the basis for the cross-reactive immunity that was discussed here 2 years ago, based on AI cases in ?ducks.

.

It may be advisable that every possible approach will be taken into account with the perspective of a ''prime'' and ''boost'' vaccination policy, even with seasonal human influenza vaccines. These could serve as adjuvant, or for increasing the immunological response to the new H5 vaccine.
I think people should increase their voice and require a precise plan from their respective governments, before the beginning of the pandemic.
Act now, act strong to avoid a disaster similar to more other we are currently seeing in some part of Africa where famine and adverse climate events put at risk millions without an immediate solution.
I would use a modified wording - firstly heard from a former defense secretary of a great nation - when I say that we know known.
 
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